ApprovalTrail

Medical device licence · 91803 · Class 2

PULMONARY FUNCTION AND METABOLIC TESTING SOFTWARE

No longer licensed: suspended: invalid quality-system certificate

Licence status Suspended: invalid quality-system certificate; first licensed August 8, 2013; ended November 30, 2020. It is in Health Canada’s archive of licences no longer in force.
Licence number
91803
Licence holder
Vyaire Medical FormerlyYorba Linda, CA, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
August 8, 2013
Ended
November 30, 2020
Devices covered
2

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • SOFTWARE KIT CARDIOSOFT
  • VMAX SOFTWARE

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.